The New York Times - Sunday, December 10, 1995

An advisory panel to the Food and Drug Administration on Friday recommended approval of a capsule implanted in the eyes of AIDS patients to help them fight off blindness.

The committee, by a vote of 6 to 1, agreed that Chiron Vision's Vitrasert implant should be approved for sale. The agency is not bound by advisory committee decisions but usually follows them.

The committee issued a strong warning that AIDS patients should not simply get the implant without additional treatment. The virus that causes the blindness, cytomegalovirus, can also invade other organs and kill AIDS patients because their immune systems cannot fight it off. Cytomegalovirus infection is harmless in most people.

While the virus can invade the entire body, 40 percent of AIDS patients get cytomegalovirus retinitis, in which the virus spreads inside the eyeball until the patient goes blind. In the 1980's, blindness was inevitable if these AIDS patients survived long enough. Now, there are two types of drugs that fight off the blindness, one taken intravenously and the other orally and intravenously.

The drugs, ganciclovir and foscarnet, must be taken twice a day for weeks or months, through a catheter that leaves patients open to infection. They also cause numerous, severe side effects. The ganciclovir is not absorbed by the body as well when taken orally.

So Chiron invented an implant that allows ganciclovir to seep directly onto the retina. In receiving it, patients undergo a 45-minute outpatient eye surgery to stick the capsule behind their retina. It is designed to work for about eight months.

A study of 173 patients showed the implant prevented progression of their eye infection about three times longer than intravenous ganciclovir, for 220 days as against 72 days.

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